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Trial record 1 of 1 for:    terikids
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Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Sanofi ( Genzyme, a Sanofi Company )
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT02201108
First received: July 17, 2014
Last updated: August 2, 2017
Last verified: August 2017
  Purpose

Primary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.

Secondary Objectives:

  • To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.
  • To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
  • To evaluate the pharmacokinetics (PK) of teriflunomide.

Condition Intervention Phase
Multiple Sclerosis Drug: Teriflunomide HMR1726 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Time to first clinical relapse after randomization [ Time Frame: over 96 weeks ]

Secondary Outcome Measures:
  • Proportion of relapse free patients [ Time Frame: at 24, 48, 72 and 96 weeks ]
  • Number of of new/newly enlarged T2 lesions [ Time Frame: at 24, 48, 72 and 96 weeks ]
  • Number of T1 Gd-enhancing T1 lesions [ Time Frame: over 96 weeks ]
  • Change in volume of T2 lesions [ Time Frame: over 96 weeks ]
  • Change in volume of T1 hypointense lesions [ Time Frame: over 96 weeks ]
  • Number of new T1 hypointense lesions [ Time Frame: over 96 weeks ]
  • Proportion of patients free of new or enlarged MRI T2-lesions [ Time Frame: at 48 weeks and 96 weeks ]
  • Brain atrophy [ Time Frame: over 96 weeks ]
  • Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test [ Time Frame: at randomization, then every 24 weeks (SDMT only) and at 96 weeks ]
  • Safety, as assessed by clinical, laboratory, ECG, and vital signs events [ Time Frame: over 96 weeks ]
  • Assessment of PK parameter - lowest concentration of drug in the blood measured after dosing (Ctrough) [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]

Estimated Enrollment: 165
Study Start Date: July 2014
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Matching placebo tablets
Drug: Placebo
Pharmaceutical form:tablet Route of administration: oral
Experimental: Teriflunomide
teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
Drug: Teriflunomide HMR1726
Pharmaceutical form:film-coated tablet Route of administration: oral

Detailed Description:
  • A screening period up to 4 weeks
  • A double-blind treatment period of up to 96 weeks for each patient
  • An open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, ie, up to a maximum of 192 weeks after randomization
  • A follow-up period of 4 weeks for patients discontinuing treatment

Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK) run-in phase in which PK samples (blood samples) will be collected from patients and then 4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to provide individual PK parameters to allow the dose adjustment to the 14mg adult-equivalent dose for the rest of the study.

Patients experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in an open label teriflunomide treatment arm up to 192 weeks from randomisation.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and have:

    • at least one relapse (or attack) in the 12 months preceding randomization or
    • at least two relapses (or attack) in the 24 months preceding randomization.
  • ≤17 years of age and ≥10 years of age at randomization.
  • Signed informed consent/assent obtained from patient and patient's legal representative (parents or guardians) according to local regulations.

Exclusion criteria:

  • EDSS score > 5.5 at screening or randomization visits.
  • Relapse within 30 days prior to randomization.
  • Treated with:

    • glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization
    • fingolimod, or intravenous immunoglobulins within 3 months prior to randomization
    • natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization,
    • cladribine or mitoxantrone within 2 years prior to randomization.
  • Treated with alemtuzumab at any time.
  • History of HIV infection.
  • Contraindication for MRI.
  • Pregnant or breast-feeding females or those who plan to become pregnant during the study.
  • Female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02201108

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 61 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02201108     History of Changes
Other Study ID Numbers: EFC11759
PIP - 2011-005249-12
U1111-1124-0983 ( Other Identifier: UTN )
Study First Received: July 17, 2014
Last Updated: August 2, 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 17, 2017